Department of Health and Human Services October 2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or we) is announcing the withdrawal of a draft guidance for industry entitled ``Applications for Premarket Review of New Tobacco Products.'' We are withdrawing this guidance because the topics discussed in the draft guidance are addressed in the final rule entitled ``Premarket Tobacco Product Applications and Recordkeeping Requirements.''

This document clarifies a term that appeared in the ``Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19,'' including in the final notice published in the Federal Register on September 14, 2021, entitled ``Ninth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19.'' Specifically, this document supplements the references to the Advisory Committee on Immunization Practices (ACIP) with references to the Centers for Disease Control and Prevention (CDC). This change is being made to clarify that what are commonly referred to as ``ACIP recommendations'' and ``ACIP standard immunization schedules'' are in fact recommendations and schedules made by the CDC after consultation with ACIP. The addition of ``CDC'' is also intended to recognize coverage of recommendations issued directly by the CDC. This clarification also applies to related guidance and opinions.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

This document corrects technical errors that appeared in the final rule published in the Federal Register on August 4, 2021 entitled ``Medicare Program; FY 2022 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2021 (FY 2022)''.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Study to Explore Early Development (SEED) Follow-up Studies. This follow-up study will allow CDC to better understand the developmental trajectory of children with autism spectrum disorder, their health outcomes and co-occurring conditions at older ages, and the associated early predictors of these outcomes, including intellectual abilities.

This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. During the October 25, 2021 meeting the Advisory Council will hear presentations about ways to support and strengthen the long-term services and supports direct care workforce, both paid and unpaid, to support access to care, improve the quality of caregiving, and meet the growing demand for long-term care dementia services. The Advisory Council will also hear about a recent workshop on the behavioral and social research and clinical practice implications of preclinical diagnosis of AD/ADRD, as well as the AD/ ADRD decadal study conducted by the National Academies of Sciences, Engineering, and Medicine. Federal representatives will provide updates on work towards the goals of the National Plan to Address Alzheimer's Disease in the last quarter.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The ACF, OHSEPR announces the intent to award four single- source grants in the amount of up to $300,000 to the following recipients: United Way Worldwide, Alexandria, VA; National Association of Social Workers, Washington, DC; American Public Human Services Association, Arlington, VA; and National Association of County Human Services Administrators, Washington, DC. The purpose of these awards is to facilitate the coordination of human services to U.S. Citizens and their dependents evacuating to the United States from Afghanistan. These organizations are key players in the leadership, coordination, or direct provision of human services after an emergency and have direct access to their constituencies and networks. U.S. citizens and their dependents (repatriates) eligible for temporary assistance under the U.S. Repatriation Program can receive up to 90 days of temporary assistance which includes transportation, food, medical care, cash assistance, temporary lodging, and case management. These awards will ensure appropriate training and technical assistance, coordination, and subject matter expertise as repatriates connect to human services entities.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice requests comments on the information collection associated with FDA research in obtaining information from pharmacists and other management at outsourcing facilities and related human prescription drug compounding businesses. The research supports a comprehensive analysis of the outsourcing facility sector that informs ongoing FDA work in this area.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 25, 2021. The document announced the withdrawal of approval of 36 abbreviated new drug applications (ANDAs) from multiple applicants as of July 26, 2021. The document indicated that FDA was withdrawing approval of the following ANDA, after receiving a withdrawal request from Yung Shin Pharmaceutical Ind. Co. Ltd., authorized U.S. agent, Carlsbad Technology, Inc./Simon Law, 5922 Farnsworth Ct., Suite 101, Carlsbad, CA 92008: ANDA 065152, Cephalexin Capsules, Equivalent to (EQ) 250 milligrams (mg) base and EQ 500 mg base. Before FDA withdrew the approval of this ANDA, Yung Shin Pharmaceutical Ind. Co. Ltd. informed FDA that it did not want the approval of the ANDA withdrawn. Because Yung Shin Pharmaceutical Ind. Co. Ltd. timely requested that approval of this ANDA not be withdrawn, the approval of ANDA 065152 is still in effect.

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) hereby gives notice that OMH is establishing a Center for Indigenous Innovation and Health Equity Tribal Advisory Committee (CIIHE TAC) and accepting nominations of qualified candidates to serve as primary and alternate delegates for the CIIHE TAC, in alignment with the 12 geographic areas served by the Indian Health Service (IHS).